NCT04931316

Brief Summary

This is a retrospective case series study that included patients who performed deep anterior lamellar keratoplasty and presented with elevated intraocular pressure during follow up.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2021

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

June 12, 2021

Last Update Submit

June 18, 2021

Conditions

Unrecognized Condition

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure values

    assessment of intraocular pressure after lamellar keratoplasty

    this is a retrospective study . collection of data from patients records over 2 months

Interventions

antiglaucomaOTHER

use antiglaucoma in ocular hypertension

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients with DALK

You may qualify if:

  • patients who were diagnosed with elevated IOP after DALK surgery performed from 2018 to 2020

You may not qualify if:

  • Patients with penetrating keratoplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Mansurah, Dakahlyia, Egypt

RECRUITING

MeSH Terms

Interventions

Antiglaucoma Agents

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • AHMED El WEHEDY, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

  • Hatem El Awady, MD

    Mansoura University

    STUDY CHAIR

  • AYA HASHISH, MD

    Mansoura University

    STUDY CHAIR

  • AMGAD EL NOKRASHY, MD

    Mansoura University

    STUDY CHAIR

Central Study Contacts

Amgad El Nokrashy, MD

CONTACT

00201022187736amgad.ali@mans.edu.eg

Aya Hashish, MD

CONTACT

00201004701791aya.hashish@mans.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

June 12, 2021

First Posted

June 18, 2021

Study Start

March 15, 2021

Primary Completion

September 20, 2021

Study Completion

October 20, 2021

Last Updated

June 23, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)